Use of unregistered vaccine illegal – FDA

MANILA, Philippines — The Food and Drug Administration (FDA) has asserted its authority to regulate the distribution and use of vaccines in the country, as it scored the “lack of appreciation” of its function by some quarters in the light of the unauthorized use of Chinese-made vaccines for COVID-19 by some officials, including members of the Presidential Security Group (PSG).

“I think it’s really a lack of appreciation. They thought FDA is like a rubber stamp. FDA is an important unit of government because it deals with everything that we eat… processed food, household substances that we have and the medicines that we put into our bodies,”FDA director general Eric Domingo said in a television interview yesterday.

“Maybe people don’t understand that we’re here not to make things difficult but to make things safe and effective for everybody,” Domingo added.

He expressed concern over the safety and efficacy of the vaccine given to PSG members.

President Duterte is expected to explain the controversy over the unauthorized use of Sinopharm vaccines on his official bodyguards, at a meeting in Davao City on Monday with the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF).

The President is in his hometown in Davao City for New Year celebrations with his family.

PSG commander Brig. Gen. Jesus Durante III earlier drew flak for admitting that his men had “independently” inoculated themselves with Chinese-made COVID-19 vaccines not yet approved by the FDA. Under Philippine laws, it’s unlawful to use or distribute drugs not registered with the DFA.

At this time, Domingo said there still are no authorized COVID-19 vaccines in the Philippines.

Without the required registration, Domingo said manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any COVID vaccine remain prohibited.

“Somebody definitely did something wrong. With the FDA law, it says it is illegal to import, distribute, manufacture, use unregistered drugs,” Domingo stressed.

Upon getting reports of illegal distribution of unregistered products, Domingo said the FDA’s regulatory enforcement began an investigation to pinpoint those responsible and file appropriate cases against them.

Except for Pfizer, Domingo said no other company has formally applied with the FDA for an authority to distribute and use their vaccines in the Philippines.

“Hindi naman po kami nagbabagal kung ‘di wala pang nag-apply sa atin na magsu-supply sa Pilipinas o mag pa-approve sa FDA (We’re not being slow, it’s just that nobody has applied yet to supply the Philippines or get FDA approval),” he said.

Domingo emphasized FDA cannot force companies to give their papers or samples of their vaccines to be tested.

The vaccine expert panel and regulators are now evaluating the application of Pfizer for emergency use authorization, he said.

“Everybody is waiting for the COVID-19 vaccine but we’re not going to allow it unless we are sure that there is certain amount of reasonable scientific evidence to believe that it is safe and effective against COVID-19,” Domingo pointed out.

PSG chief explanation sought

Meanwhile, Senate Minority Leader Franklin Drilon said the PSG chief should be made to explain before the Senate convened as a committee of the whole his admission that members of his unit had “independently” inoculated themselves with unregistered COVID vaccines.

“The most important ‘who’ and ‘how’ of the story remain a mystery. The PSG commander is deliberately withholding the basic questions of who and how from the public,” said Drilon. “In my view, the PSG commander must be called and must appear in the investigation of the Committee of the Whole to shed light on this issue.”

Drilon said Durante took “full responsibility” for the administration of the unregistered vaccine to his members, admitting that they did the vaccination by themselves and without the knowledge of the President or any other agency.

“All they give to the public are alibis, excuses and lies. There is more to it that will be revealed to the committee once Brig. Gen. Durante appears in our hearing. The Senate must summon the PSG commander,” he said.

“Who else was involved? How did unregistered Covid-19 vaccines enter the country? Who imported it from China?” he added.

Drilon, among the first to call out the illegal administration of the China-made vaccine to some members of the Cabinet, the PSG and the military, strongly supports the investigation of the National Bureau of Investigation (NBI) on the issue.

“I support the order of Justice Secretary Menardo Guevarra for the NBI to look into unauthorized inoculations against COVID-19 using unregistered vaccines. Laws appear to have been violated,” Drilon pointed out.

“The DOJ and the NBI are mandated by law to investigate. No one is above the law. The Rule of Law must be the rule, rather than an exception,” the minority leader said.

Drilon, a former justice secretary, had earlier said that the Food and Drug Administration Law or Republic Act No. 3720, as amended by Republic Act No. 9711, prohibits the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded or any health product which, although requiring registration, is not registered with the FDA pursuant to this Act.”

Drilon warned that those involved in the unauthorized use or distribution of Sinopharm vaccine face a penalty of imprisonment ranging from one year to 10 years or a fine of not less P50,000 but not more than half a million, or both. The manufacturer, importer, or distributor faces stiffer penalties of five to 10 years imprisonment and a fine of P500,000 to P5 million, he warned.

“The FDA’s assertion that it has not given any emergency use authorization to any vaccine for Covid-19 is enough basis to prosecute those involved in this illegal inoculation. Our authorities should look into it and prosecute those involved,” he said. — Edu Punay, Edith Regalado